Address
Form of work Job Descprition:
Roles & Responsibilities:
Roles & Responsibilities:
- Develop and execute CSV documentation, including validation plans, protocols, and reports for computerized systems, including equipment control systems, data management systems, and laboratory information management systems.
- Collaborate with cross-functional teams to ensure that computerized systems are designed, installed, and maintained in compliance with GxP guidelines and industry regulations, including 21 CFR Part 11 and GAMP 5.
- Provide technical support for computerized systems, including troubleshooting and problem-solving.
- Conduct risk assessments to identify potential areas of vulnerability and develop mitigation strategies.
- Develop and implement change control processes for computerized systems to ensure that changes are controlled, documented, and validated.
- Train end-users on computerized systems and ensure that they are following best practices for data integrity, security, and compliance.
- Maintain knowledge of industry trends and regulatory requirements and ensure that the company's computerized systems are up-to-date and compliant.
- Bachelor's degree in engineering, Computer Science, or related field.
- 3+ years of experience in CSV in a highly automated pharmaceutical plant.
- Knowledge of industry regulations and standards, including 21 CFR Part 11, GAMP 5, and ICH guidelines.
- Familiarity with computerized systems, including control systems, data management systems, and laboratory information management systems.
- Strong knowledge of risk management principles, including FMEA and HAZOP.
- Excellent communication and problem-solving skills.
- Ability to work collaboratively with cross-functional teams.
- Familiarity with manufacturing processes in a pharmaceutical plant.
- Experience with validation processes and procedures.
